U.S. patent number 7,682,327 [Application Number 10/839,126] was granted by the patent office on 2010-03-23 for mobile heart-lung machine.
This patent grant is currently assigned to Lifebridge Medizintechnik AG. Invention is credited to Karsten Kirchhof.
United States Patent |
7,682,327 |
Kirchhof |
March 23, 2010 |
Mobile heart-lung machine
Abstract
The present invention provides a heart-lung machine which can be
carried by one person and can be used independently from an
external power supply, consisting of at least three modules (1, 2,
3), wherein a first module (1) contains the blood circulating
elements which are necessary for the function of a heart-lung
machine, a second module (2) contains a pump drive (9) and an
electronic measuring equipment and a control logic (11) and a third
module (3) contains the programming unit (14), whereas the second
unit is separably connected to the first and the third module.
Inventors: |
Kirchhof; Karsten (Burghaun,
DE) |
Assignee: |
Lifebridge Medizintechnik AG
(Ampfing, DE)
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Family
ID: |
28799157 |
Appl.
No.: |
10/839,126 |
Filed: |
May 6, 2004 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20050004480 A1 |
Jan 6, 2005 |
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Foreign Application Priority Data
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May 9, 2003 [DE] |
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203 07 256 |
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Current U.S.
Class: |
604/4.01;
604/6.16; 604/6.13; 604/6.11; 604/6.1; 604/6.06; 604/27; 422/46;
422/45; 422/44 |
Current CPC
Class: |
A61M
1/3666 (20130101); A61M 1/1698 (20130101); A61M
1/3667 (20140204); A61M 1/3621 (20130101); A61M
2205/12 (20130101); A61M 2205/8206 (20130101) |
Current International
Class: |
A61M
37/00 (20060101); A61M 1/00 (20060101) |
Field of
Search: |
;600/6.06,6.1,6.11,6.13,6.16 ;422/44,45,46 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2 361 604 |
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Aug 2001 |
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CA |
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195 36 204 |
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Jan 1997 |
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DE |
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29719899 |
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Jan 1998 |
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DE |
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199 05 937 |
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Jul 2000 |
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DE |
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200 08 961 |
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Oct 2001 |
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DE |
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Primary Examiner: Deak; Leslie R
Assistant Examiner: Marcetich; Adam
Attorney, Agent or Firm: Gifford, Krass, Sprinkle, Anderson
& Citkowski, P.C.
Claims
The invention claimed is:
1. A heart-lung machine which can be carried by one person
comprising: a first module which contains blood circulating
elements which are necessary for the function of the heart-lung
machine, said blood circulating elements including a reservoir, a
blood pump and an oxygenator, said blood circulating elements
contained in a first unitary housing, a second module physically
separable from said first module, said second module containing a
pump drive which mechanically drivingly engages said pump only when
said first and second modules are connected together, and a control
logic, said second module being isolated from blood processed by
said blood circulating elements, said pump drive and said control
logic contained in a second unitary housing, and a third module
physically separable from said first and second module, said third
module containing a programming unit, said programming unit
including a computer programmed to adjust and prime the blood
circulating elements, said programming unit and said computer
contained in a third unitary housing, said third module being
removable from said first and second module after priming and
adjustment of said blood circulating elements whereupon operation
of said first and second module continues independently powered by
an external power source outside the third module.
2. A heart-lung machine as claimed in claim 1, wherein the second
module comprises valves for adjusting an internal bypass.
3. A heart-lung machine as claimed in claim 1, wherein the second
module comprises an emergency energy supply and operating units for
an emergency operation of the machine.
4. A heart-lung machine as claimed in claim 1, wherein the second
module comprises a storage medium for transferring information from
the third module to a fourth module.
5. A heart-lung machine as claimed in claim 1, wherein the third
module comprises a user interface, a computer and a main power
supply.
6. A heart-lung machine as claimed in claim 1, wherein the first
and the second module can be joined together and can be carried by
one person.
7. A heart-lung machine as claimed in claim 1, wherein a connection
between the second and the third module is established by a simple
current linkage which compulsory conjoins when assembling the
modules.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a mobile heart-lung machine for
maintaining the blood circulation.
2. Description of the Prior Art
For maintaining a person's circulation, anoxemic venous blood is
removed from the person by means of a heart-lung machine with a
cannula and fed to an oxygenator by a blood pump to avoid or
eliminate a circulatory arrest or lack of perfusion during an
operation as the result of an accident or some other organ failure.
In the oxygenator, which performs the function of an artificial
lung, the blood is enriched with oxygen and CO.sub.2 is removed.
Subsequently, the oxygen-rich arterial blood is fed back to the
patient's circulation through a cannula after cleaning it in an
arterial filter. Heart-lung machines of this type are used for
stationary applications in hospitals.
DE 43 43 334 A1 discloses a generic heart-lung machine for mobile
use. It has a supporting structure, provided with carrying handles
at the front and back, having a bridge-like structure and having
standing feet protruding downward. For fixing all component parts
of the heart-lung machine, corresponding fastening means are
provided. However, in the case of this machine, the functionally
important elements are arranged such that they are freely
accessible and are consequently not protected against damage, which
may impair serviceability during use. In addition, the machine must
always be carried by two people.
A mobile heart-lung machine provided with a set of tubes is also
disclosed by DE 197 02 098 A1. This machine comprises a loop for
feeding blood to an artery, a second loop for removing blood from a
vein, a venous reservoir, an oxygenator, a blood pump which is
preferably designed as a roller pump, and an oxygen dispenser in
the form of an oxygen concentrator connected to the pump on the
drive side. Furthermore, the machine has a controller for the
oxygen concentrator and the delivery rate of the pump and also
connections for a decentralized energy supply and/or for an
electrical energy store. Although this heart-lung machine is also
intended in particular for mobile use, it cannot normally be
handled by one person on account of its size and weight.
Owing to the confined space in an ambulance, it is virtually
impossible to take this machine along on an emergency call-out in a
ready-to-operate state. The haste required in emergency call-outs,
in particular in the case of patients suffering from a failure of
the cardiopulmonary function, makes the requirement of setting up
the machine prior to use disadvantageous. In addition, after each
time they are used, the aforementioned heart-lung machines have to
be newly set up and cleaned in a complicated procedure before they
are used again. As a result, immediate re-use is not possible.
DE 199 05 937 discloses a heart-lung machine, wherein the elements
which circulate the blood on the one hand and the drive and
automatic control elements on the other hand are arranged in two
separate modules.
It is therefore the object of the present invention to provide a
heart-lung machine suitable for mobile use. In particular, it is an
object of the present invention to provide a heart-lung machine
that can be carried and handled by one person. A further object is
that the heart-lung machine is constructed in such a way that the
respective elements can easily be exchanged, and thus after use the
heart-lung machine can easily and quickly be prepared for the next
use.
SUMMARY OF THE INVENTION
The invention relates to a heart-lung machine which can be carried
by one person and can be used independently of an external power
supply, consisting of at least three modules (1, 2, 3), wherein a
first module (1) contains the blood circulating elements which are
necessary for the function of a heart-lung machine, a second module
(2) contains a pump drive (9) and an electronic measuring equipment
and a control logic (11) and a third module (3) contains the
programming unit (14), whereas the second unit is separably
connected to the first and the third module.
Preferably, the heart-lung machine according to the invention
consists of three modules.
In a preferred embodiment of the invention, at least one module of
the heart-lung machine is affixed to a housing. In case of a
heart-lung machine consisting of three modules, all modules are
preferably affixed to a housing.
The present invention furthermore provides a heart-lung machine,
wherein the modules can seperably be connected to each other by
means of handholds.
Optionally, the housings can seperably be connected to each other
by means of handholds.
In another embodiment of the invention, the first module of the
mobile heart-lung machine comprises a blood-pump (5), an oxygenator
(6), a filter (8) and a blood conveying system.
The first module of the heart-lung-machine may comprise a
connection for a venous cannula, a reservoir (4) and a connection
for an arterial cannula.
The second module of the heart-lung-machine may comprise a pump
drive (9), an electronic measuring equipment and a control logic
(11) and valves for adjusting the internal bypass.
The second module of the heart-lung machine preferably comprises an
emergency energy supply and operating units for the emergency
operation.
The second module of the heart-lung machine may comprise joints to
the first and the third module.
Preferably, the second module of the heart-lung machine comprises a
storage medium for transferring information from a third module to
another third module.
In a preferred embodiment of the invention, the third module of the
heart-lung machine comprises an operating surface (13), a computer
(14) and a main power supply (15).
In a more preferred embodiment of the invention, the first and the
second module of the heart-lung machine can be joined together and
can be carried by one person.
Optionally, the first module together with the second module can
act as a heart-lung machine without the third module.
Preferably, the connection between the second and the third module
of the heart-lung machine is established by a simple current
linkage, which compulsory conjoins when assembling the modules or
housings.
The invention furthermore provides a module defined above as the
first module.
The invention also provides a module defined above as the second
module.
The invention also provides a module defined above as the third
module.
Finally, the invention provides a heart-lung machine consisting of
a first module as defined above and a second module as defined
above.
BRIEF DESCRIPTION OF THE DRAWING
A better understanding of the present invention will be had upon
reference to the following detailed description when read in
conjunction with the drawing in which:
FIG. 1 is a plan diagrammatic view illustrating a preferred
embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
The modular construction of the heart-lung machine of the invention
ensures easy and quick disassembling and reassembling of the
heart-lung machine.
Preferably, the heart-lung machine is consists of 3 functional
units (modules).
The functional unit wherein the elements coming into contact with
blood, such as reservoir (4), pump head (5), oxygenator (6)
provided with a heat exchanger (7) or an arterial filter (8), can
be embedded is referred to as "patient module" (1).
The functional unit wherein the pump drive (9) provided with a
mechanical hand crank (10), the essential sensor part (11) and a
backup storage battery (12) can be embedded is referred to as
"automatic control module" (2).
The basic unit comprising the operating surface (13) (e.g. touch
screen), a computer (14), e.g. a small PC, and a main power supply
(15) is referred to as "basic module" (3).
The term "module" as used in the present invention means a unit
wherein the respective parts are stably affixed to a support. In
the simplest case this support can be a base rack. However, an open
or closed housing is preferred. Though the single parts of the unit
are stably affixed to the support and/or joined together, the
connection can be loosened. The connections are preferable plug-in
connections. Preferable all elements are arranged in a housing in
order to protect them from mechanical damage. Parts which are not
so sensitive may also be arranged outside the housing. The
construction of the modules is not limited provided that the single
modules per se or a combination of two or three modules can be
carried by one person. Therefore, the modules should be compact and
must not be constructed in a bulky way. In order to be portable by
one person, the size of the heart-lung machine preferably
corresponds approximately to the size of an executive case and the
weight is preferable not more than 20 kg.
It is the object of the heart-lung machine according to the present
invention to maintain and/or replace the cardiopulmonary function.
Such a heart-lung machine in general consists of a venous feeding
of the patient's blood, a reservoir for balancing the volume, a
blood pump for actively supporting the blood-circulation, an
oxygenator for enriching the blood with oxygen and for eliminating
CO.sub.2, a heat exchanger for tempering (heating or cooling of)
the blood, an arterial filter provided with a bypass for filtrating
the blood, valves for connecting an internal circulation as well as
an arterial tube for returning the blood to the patient. The
internal bypass is required in order to fill the machine with a
blood substitute and to vent the complete system before it is
connected to the patient's circulation (priming). The internal
volumes should be small in order to keep the volume of the blood
substitute as small as possible. Integrating the blood-circulating
elements in the housing or moulding them in the plastic housing is
also possible to fulfill this feature.
In order to integrate or arrange the very sensitive sensor in or at
the respective measuring points, the control module is preferably
pre-mounted with the patient module and tested so that the future
user receives an element in the form of a plug-in, which then has
to be arranged and fixed to the basic module. The plug-in
containing the blood-circulating elements like the venous feeding
of the patient's blood, reservoir, blood pump, oxygenator, arterial
filter provided with a bypass and valves is separated from the
control module and disposed after use. The control module is sent
back to the manufacturer for recycling. The patient's data saved in
the automatic control module and in the basic module can be read
out via a data line/port and the data can be made available to the
attending hospital for the patient's file or for statistical
purposes. By applying the above described operation, an accurate
performance of the set up is assured. The "on-site set up" under
more difficult conditions as one source of error is essentially
limited to the filling and venting of the heart-lung machine.
The necessary software for the drive and automatic control of all
processes and operations is preferably contained in a small PC in
the basic module. The basic operating data are provided by a basic
program. Possible necessary changes can be carried out via the
operating surface (e.g. touch screen). These changes can also be
saved.
The mobile heart-lung machine is provided with two storage
batteries as power supply. The primary energy supply in the basic
module is assured by the main storage battery. The control module
is provided with a backup storage battery which keeps up the
emergency operation over a limited period of time.
A further advantage of the present invention is that after basic
setting by the basic module the control module together with the
patient's module can also be operated self-sufficiently, that is
without the basic module, with an external power supply, e.g. car
battery. No further changes or adjustments of the control
parameters can be made, however, the number of applications is no
longer dependent on the number of the basic modules.
In contrast to other prior art publications like DE 199 05 937 C1,
the present invention relates to an heart-lung machine that can
easily be carried by one person and consists of various plug-ins
provided with the blood-circulating elements, the automatic control
elements and sensors for measuring for example the blood
temperature, the blood pressure, the oxygen saturation, the volume
flow, the internal pressures as well as the basic power supply and
software.
With the respective antennas and sensors, inter alia the
temperatures at the arterial inlet, the arterial outlet as well as
at the oxygenator, the pressure at the venous inlet, at the
arterial outlet, between the pump and the oxygenator, the pressure
of the O.sub.2-supplement, the oxygen saturation at the venous
inlet and the arterial outlet, the detection of air bubbles at the
venous inlet and the venous outlet as well as the measurement of
the blood flow at the arterial outlet are measured.
At the manufacturer's plant the individual modules can be mounted
and placed in the housings which protect all elements against
external mechanical damage.
The blood guiding in the inside of the patient module is not
effected by pre-shaped set of tubes as disclosed by DE 197 02 098
A1, but by a pre-shaped blood guiding system. The advantage of such
blood guiding is a lower mechanical strain of the blood, better
haemodynamics as well as lower shear rates.
The heart-lung machine which can be carried and operated by one
person can be used both directly on-site at an emergency call-out
and in a hospital or in a cardiologic practice. A mere in-patient
employment in hospitals is also possible.
The connection to the control module is preferably functional, both
electrical and mechanical. The electrical connections may connect
the automatic control module with the sensor parts for analysis
purposes and may afford triggering of the valves. The mechanical
connection affords power transmission from the pump drive in the
automatic control module to the pump head in the patient
module.
In case the automatic control module breaks down, the user has the
possibility of keeping up the essential function of the heart-lung
machine by manually operating via a hand crank. The automatic
control module preferably consists of a housing showing the devices
for the complete electronic measurement equipment and automatic
control logic, the pump drive, the valves for adjusting the
internal bypass, the transitional power supply, the operating unit
for the emergency operation, the contacts for the external sensors
(temperature, pressure and oxygen saturation, volume flow
measurement), the connections to the patient module, the
connections to the basic module, the storage medium for
transferring information between one basic module and another basic
module.
The automatic control module can be arranged in the patient module
and is joined with this in the factory. The functional tests and
the subsequent calibration are carried out simultaneously. Both
modules are supplied to the user as one unit. After use the patient
module and automatic control module can be disconnected by the
user. The automatic control module can be sent back to the
manufacturer in order to be reused after appropriate
inspections.
The basic module preferably consists of a housing having a small
PC, a LCD-display provided with an operating surface, e.g. touch
screen, main power supply, charge devices and connections to the
automatic control module.
The purposes of the basic module are to provide the necessary
energy, controlling and monitoring the charging, the fault-tolerant
and concise operation of the complete system, recording all
relevant operation data, documentation of the activities made by
the user and the connection to external data processing devices for
transferring the recorded information.
The electrical connection between the basic module and automatic
control module can be for example a quadripol and serves for
transferring energy and information.
The user may keep the basic module, and it can be connected with
the unit consisting of automatic control module and patient module
by the user before use.
The main advantage over already known heart-lung-machines is that
the control module may be returned to the manufacturer again and
again which results in a very frequent control of the elements
relevant for the control so that software updates can easily be
transferred to all applications and the sensitive sensors can be
checked, adjusted, revised and calibrated again and again at the
plant.
The most complicated operation when mounting the separate system
elements is the connection of the patient module with the automatic
control module. However, it is now possible that this operation is
conducted by the manufacturer, and thus the user is relieved. Above
all, in case of an emergency call-out possible sources of error are
thus eliminated. As mentioned, before leaving the plant, the
patient module and automatic control module together may be tested
and calibrated. Thus, the highest accuracy of the measured sensor
data are obtained and misoperation by inappropriately joining the
quadripolar electrical and mechanical connections between the
patient module and automatic control module by the user is
excluded.
Since the most complicated connection which brings up the most
misoperation can be carried out at the plant, the structure of the
heart-lung machine may be simpler and, for example, the machine may
be provided with special devices. As a result, the costs for the
development and production may be lowered.
Since the connection between the basic module and automatic control
module is only necessary for an information and energy transfer, it
is possible to use future generations of the heart-lung machine
according to the present invention, possibly after a software
update of the basic module, together with the existing basic module
of the first generation. Therefore, the user's investment in the
basic module pays off in the future.
This advantage can be illustrated for example in the case of
supplier's problems concerning the delivery of the pump head.
In such a case it would be possible to modify the automatic control
module with a suitable adaptation and check it before joining the
patient module with a new pump head.
All elements of the automatic control module have to be checked and
calibrated at regular intervals. Using this concept, the compliance
with these intervals of inspection is not applicable, since the
user keeps only the basic module which in general comprises no
security relevant elements.
After consultation with the appropriate medical authorities it
could be possible to implement a permanent set of emergency
programs which, in case of a breakdown of the basic module, may be
used with external energy sources (e.g. car battery). These
external energy sources are not ideal and detailed operation data
cannot be recorded. However, this alternative is to be preferred
over a total breakdown of the system.
During disaster operation or multiple crashes it may be desirable
to use several heart-lung machine-systems. The number of on-site
basic modules limits the number of application cases. With the
heart-lung machine according to the present invention it is
possible to adjust the system and to effect the priming by the
basic module, afterwards to disconnect the basic module from the
automatic control module and further use the automatic control
module and patient module with an external energy supply. In such a
case, the basic module would be available for medicating a further
patient. Therefore, only the number of the automatic control
module/patient module units would limit the number of patients to
be medicated.
LIST OF DESIGNATIONS
1 Patient module 2 Control module 3 Basic module 4 Reservoir 5 Pump
head 6 Oxygenator 7 Heat exchanger 8 Arterial filter 9 Pump drive
10 hand crank 11 Electronic measuring equipment and control logic
12 Backup storage battery 13 Touch screen 14 Computer 15 Main power
supply
* * * * *